Product Complaints Specialist II - AID

Company: Werfenlife SA.
Location: San Diego
Posted on: September 18, 2023

Job Description:

Country United States About the PositionOverviewWerfenWerfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.Job SummaryAs a member of the Product Complaint Team receives and investigates product complaints via phone, email or SAP (Inova's ERP system). The Product Complaint Specialist II responds to customer complaints on a broad range of technical questions regarding assay performance and other assay related concerns. Responsible for assessing customer issues and using judgement and technical expertise to carry out a variety of complaint investigation-related activities, including troubleshooting, investigations, product testing and providing complaint resolution to customers within an FDA regulated environment. May collaborate with other internal teams and global affiliates to respond to product inquiries and complaints. Interpersonal skills and technical product knowledge and expertise are critical to responding to daily customer-centric activities. This position works under limited supervision to provide exceptional technical and customer service to customers.ResponsibilitiesKey Accountabilities--- Receives, analyzes, and decides best course of action to investigate customer complaints to determine root cause; follows up with customers in a professional, timely manner to close complaints. --- Responsible for proactively and professionally working with customers to resolve complaints, provide information and education where appropriate, and meet or exceed customer expectations. Provides customer-focused resolution communication directly to customers, affiliates and team members.--- Possesses an advanced understanding of Inova's systems (both reagents and equipment).--- Meets or exceeds department customer service and investigation standards.--- In collaboration with team, participates in initial troubleshooting of customer calls as needed. Provides guidance to junior members of the team.--- Independently conducts investigations for product failures or customer requests for assistance; includes conducting advanced and escalated complaint investigations. --- Conducts laboratory testing to support investigations and customer inquiries.--- Using technical expertise and judgement, escalates potential product performance issues or quality systems issues. Collaborates with other departments and original equipment manufacturer (OEM) to troubleshoot and resolve escalated failures.. --- Ensures accurate documentation of the complaint evaluation, MDR reportability, risk assessment and investigation results, in accordance with Inova SOPs and regulatory requirements. --- Reviews complaint investigations for accuracy and completeness.--- Maintains records in SAP performs laboratory activities, in accordance with SOPs and good documentation practices (GDP). --- Generates reports, as required, to document complaint investigations and or projects, including performing complaint trend analysis.--- Performs specialized tasks, under the direction of department management, in accordance with standard operating procedures. --- Works on assigned projects and provides observations, recommendations and reports to management.--- Monitors and maintains laboratory supplies and equipment, with approval of department management.--- Performs other duties and projects as assigned to meet company and department objectives.--- Complies with applicable Inova standard operating procedures (SOPs), ISO 13485, FDA 21 CFR and other applicable Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and other regulatory and administrative policies.--- Reflects the values of Werfen and Inova in the quality of work and in working relationships.Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.QualificationsMinimum Knowledge & Experience required for the position:--- Bachelor's degree in biological science required.--- 4+ years of experience with diagnostic reagents or instruments required.--- 4+ years of technical or complaint related experience in a call center environment required. --- 2+ years; experience working in a regulated life sciences environment required. --- Medical device, IVD, autoimmunity related experience strongly preferred.Skills & Capabilities:--- Thorough understanding of quality systems regulations.--- Strong Microsoft Office suite and ERP systems knowledge, preferably SAP required.--- Proven ability to multi-task, work under pressure, adapt and thrive in a fast-paced customer support/call center environment strongly preferred.Travel requirements:--- Less than 5%Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/VWe operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.The salary range for this position is currently $66,000-$90,000. Individual compensation is based on the candidate's qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs. OverviewWerfen Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic... OverviewWerfen Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic... OverviewWerfen Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic...

Keywords: Werfenlife SA., San Diego , Product Complaints Specialist II - AID, Other , San Diego, California